Blue Light for Donor Site Healing in Burn Patients

NCT07453927 | Recruiting

• 1 other identifier: 3926 - Prot. 2707/2025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The donor site (DS) in patients with severe burns is often associated with complications that may delay healing and negatively affect clinical outcomes. Impaired re-epithelialization, pain, inflammation, and risk of infection represent relevant challenges in burn care. Blue light (BL) photobiomodulation has demonstrated beneficial effects in different types of skin lesions, including modulation of inflammation and stimulation of tissue repair. Therefore, BL therapy may represent an innovative and non-invasive strategy to enhance DS healing and improve overall recovery. Methods: This protocol describes an interventional, controlled, prospective, single-center, post-market clinical study enrolling 25 patients with intermediate and deep burn injuries. A CE-marked device emitting BL will be used. Each participant will receive both treatments through an intra-patient controlled design: one DS area will be treated with Standard of Care (SoC) alone, while a second DS will receive SoC combined with BL therapy. This approach allows direct comparison of clinical outcomes within the same patient, minimizing inter-individual variability. The primary outcome is the comparison of DS healing time between areas treated with BL plus SoC and those treated with SoC alone. Secondary outcomes include assessment of wound bed characteristics using the Wound Bed Score (WBS), evaluation of pain intensity during the healing process through the Numeric Pain Rating Scale (NRS), and identification of clinical signs of infection by performing skin swabs on both treated and untreated areas. Safety will be assessed by monitoring local adverse reactions related to BL exposure, such as erythema, burning sensation, heat perception, skin irritation, or pruritus. Long-term scar quality will be evaluated at 1 and 3 months after complete healing using the Vancouver Scar Scale (VSS), allowing comparison of aesthetic and functional outcomes between the two treatment approaches. Follow-up visits at 1 and 3 months will also enable detection of late adverse events and confirmation of the persistence of therapeutic effects. Discussion/Conclusion: BL photobiomodulation appears to be a promising and well-tolerated adjunctive therapy for DS management in burn patients. This study aims to generate clinical evidence supporting its effectiveness and potential integration into routine burn care practice.

Conditions

Donor Site Complication; Burn; Photobiomodulation Therapy; Blue Light

Keywords

donor site; burns; photobiomodulation; blue light; healing

Outcome Measures

Primary Outcomes (1)

• Donor Site Healing Time

  To compare the healing times of skin Donor Site treated with Standard of Care (SoC) in combination with Blue Light therapy compared to those treated with SoC.

  From enrollment to the end of treatment at 4-5 weeks

Secondary Outcomes (5)

• Wound Bed Score (WBS)

  From enrollment to the end of treatment at 4-5 weeks

• Numeric Pain Rating Scale (NRS)

  From enrollment to the end of treatment at 4-5 weeks

• Signs of Infection

  From enrollment to the end of treatment at 4-5 weeks

• Local Adverse Reactions

  From enrollment to the end of treatment at 4-5 weeks

• Vancouver Scar Scale (VSS)

  1 and 3 months after healing

Study Arms (2)

Experimental treatment

EXPERIMENTAL

Standard treatment + Blue Light

Device: Photobiomodulation with blue light

Standard Treatment

NO INTERVENTION

Standard Treatment

Interventions

Photobiomodulation with blue light DEVICE

The BL will be applied to the entire DS for 60 seconds, with one session per week, for a total of 3-4 weeks depending on the healing process.

Experimental treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with intermediate-deep burns with Total Body Surface Area (TBSA) \> 10% requiring surgical treatment with escharectomy, presenting at least two Donor Site.
• Patients over 18 years of age;
• Patients who have signed the informed Consent Form (ICF) and understood the purpose of the study, or, if unable to give consent personally due to their condition, their legal guardian.

You may not qualify if:

• Intermediate-deep burns TBSA \< 10% or superficial burns;
• Patients under the age of 18;
• Patients who are participating in other clinical trials with drugs or medical devices;
• Patients with neoplasms or other conditions requiring the use of cytostatic or immunosuppressive drugs;
• Patients with conditions that induce skin photosensitivity;
• Pregnant or breastfeeding women;
• Patients or relatives who are unable to understand the purposes of the trial;

Sponsors & Collaborators

• AUSL Romagna Rimini: lead

Study Sites (1)

U.O. Centro Grandi Ustionati - Osp. Maurizio Bufalini

Cesena, Forlì-Cesena, 47521, Italy

RECRUITING

Related Publications (24)

• Purpura V. Blue Led Light in Burns: A New Treatment's Modality. J Clin Investig Dermatol [Internet]. 2021 [cited 2026 Jan 26];9(2). Available from: https://www.avensonline.org/fulltextarticles/JCID-2373-1044-09-0072.html

  BACKGROUND

• Zhang D, Leong ASW, McMullin G. Blue light therapy in the management of chronic wounds: a narrative review of its physiological basis and clinical evidence. Wounds. 2023 May;35(5):91-98. doi: 10.25270/wnds/22097.

  PMID: 37163654 BACKGROUND

• Ricci E, Pittarello M. Blue light photobiomodulation for reactivation of healing in wounds not responding to standard therapy. J Wound Care. 2023 Nov 2;32(11):695-703. doi: 10.12968/jowc.2023.32.11.695.

  PMID: 37907354 BACKGROUND

• Fraccalvieri M, Amadeo G, Bortolotti P, Ciliberti M, Garrubba A, Mosti G, Bianco S, Mangia A, Massa M, Hartwig V, Salvo P, Ricci EB. Effectiveness of Blue light photobiomodulation therapy in the treatment of chronic wounds. Results of the Blue Light for Ulcer Reduction (B.L.U.R.) Study. Ital J Dermatol Venerol. 2022 Apr;157(2):187-194. doi: 10.23736/S2784-8671.21.07067-5. Epub 2021 Sep 9.

  PMID: 34498454 BACKGROUND

• Dini V, Papadia F, Francesco FD, Salvo P, Paolicchi A, Janowska A, Chiricozzi A, Oranges T. Potential correlation of wound bed score and biomarkers in chronic lower leg wounds: an exploratory study. J Wound Care. 2017 Sep 1;26(Sup9):S9-S17. doi: 10.12968/jowc.2017.26.Sup9.S9.

  PMID: 28880755 BACKGROUND

• Wiechula R. The use of moist wound-healing dressings in the management of split-thickness skin graft donor sites: a systematic review. Int J of Nursing Practice [Internet]. 2003 Apr [cited 2026 Jan 26];9(2). Available from: https://onlinelibrary.wiley.com/doi/10.1046/j.1322-7114.2003.00417.x

  BACKGROUND

• Kolimi P, Narala S, Nyavanandi D, Youssef AAA, Dudhipala N. Innovative Treatment Strategies to Accelerate Wound Healing: Trajectory and Recent Advancements. Cells. 2022 Aug 6;11(15):2439. doi: 10.3390/cells11152439.

  PMID: 35954282 BACKGROUND

• Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.

  PMID: 2373734 BACKGROUND

• Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.

  PMID: 18487245 BACKGROUND

• Paggi Battistino, Granara Debora, Tiziana L, Tesei Martina, Falanga Vincent. Wound Bed Score (WBS): A pilot Italian evaluation of a new modified instrument [Internet]. Unpublished; 2015 [cited 2026 Jan 27]. Available from: https://www.researchgate.net/doi/10.13140/RG.2.1.3176.4565

  BACKGROUND

• Carboni RM, Goncalves MLL, Tacla EM, Silva DFT, Bussadori SK, Fernandes KPS, Horliana ACRT, Mesquita-Ferrari RA. The effects of photobiomodulation using LED on the repair process of skin graft donor sites. Lasers Med Sci. 2022 Apr;37(3):1881-1890. doi: 10.1007/s10103-021-03447-2. Epub 2021 Oct 29.

  PMID: 34713365 BACKGROUND

• Vaghardoost R, Momeni M, Kazemikhoo N, Mokmeli S, Dahmardehei M, Ansari F, Nilforoushzadeh MA, Sabr Joo P, Mey Abadi S, Naderi Gharagheshlagh S, Sassani S. Effect of low-level laser therapy on the healing process of donor site in patients with grade 3 burn ulcer after skin graft surgery (a randomized clinical trial). Lasers Med Sci. 2018 Apr;33(3):603-607. doi: 10.1007/s10103-017-2430-4. Epub 2018 Jan 24.

  PMID: 29368069 BACKGROUND

• Prado TP, Zanchetta FC, Barbieri B, Aparecido C, Melo Lima MH, Araujo EP. Photobiomodulation with Blue Light on Wound Healing: A Scoping Review. Life (Basel). 2023 Feb 18;13(2):575. doi: 10.3390/life13020575.

  PMID: 36836932 BACKGROUND

• de Freitas LF, Hamblin MR. Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy. IEEE J Sel Top Quantum Electron. 2016 May-Jun;22(3):7000417. doi: 10.1109/JSTQE.2016.2561201.

  PMID: 28070154 BACKGROUND

• Ribeiro RVE, Martuscelli OJD. Split-thickness skin graft donor-site dressings: is it possible to establish the ideal dressing based on a literature review? Revista Brasileira de Cirurgia Plástica (RBCP) - Brazilian Journal of Plastic Sugery. 2018;33(1):119-29.

  BACKGROUND

• Serebrakian AT, Pickrell BB, Varon DE, Mohamadi A, Grinstaff MW, Rodriguez EK, Nazarian A, Halvorson EG, Sinha I. Meta-analysis and Systematic Review of Skin Graft Donor-site Dressings with Future Guidelines. Plast Reconstr Surg Glob Open. 2018 Sep 24;6(9):e1928. doi: 10.1097/GOX.0000000000001928. eCollection 2018 Sep.

  PMID: 30349793 BACKGROUND

• Choong E, Jurat D, Sandeep B, Rainnie B, Manzanero S, Dowsey M, McPhail S, Choong PF, Wood F. The impact of infection on length of stay in adult burns: A scoping review. Burns. 2024 May;50(4):797-807. doi: 10.1016/j.burns.2024.01.003. Epub 2024 Jan 15.

  PMID: 38307765 BACKGROUND

• Bache SE, Martin L, Malatzky D, Nessler M, Frank A, Douglas HE, Rea S, Wood FM. First do no harm: A patient-reported survey of split skin graft donor site morbidities following thin and super-thin graft harvest. Burns. 2024 Feb;50(1):41-51. doi: 10.1016/j.burns.2023.10.016. Epub 2023 Nov 2.

  PMID: 38008702 BACKGROUND

• Humrich M, Goepel L, Gutknecht M, Lohrberg D, Blessmann M, Bruning G, Diener H, Dissemond J, Hartmann B, Augustin M. Health-related quality of life and patient burden in patients with split-thickness skin graft donor site wounds. Int Wound J. 2018 Apr;15(2):266-273. doi: 10.1111/iwj.12860. Epub 2017 Dec 15.

  PMID: 29243343 BACKGROUND

• Guldogan CE, Kendirci M, Tikici D, Gundogdu E, Yasti AC. Clinical infection in burn patients and its consequences. Ulus Travma Acil Cerrahi Derg. 2017 Nov;23(6):466-471. doi: 10.5505/tjtes.2017.16064.

  PMID: 29115647 BACKGROUND

• Bradow BP, Hallock GG, Wilcock SP. Immediate Regrafting of the Split Thickness Skin Graft Donor Site Assists Healing. Plast Reconstr Surg Glob Open. 2017 May 23;5(5):e1339. doi: 10.1097/GOX.0000000000001339. eCollection 2017 May.

  PMID: 28607863 BACKGROUND

• Depoortère C, Duquennoy-Martinot V. Innesti cutanei. EMC - Tecniche Chirurgiche - Chirurgia Plastica¸ Ricostruttiva ed Estetica. 2020 Mar 1;18(1):1-11.

  BACKGROUND

• Voineskos SH, Ayeni OA, McKnight L, Thoma A. Systematic review of skin graft donor-site dressings. Plast Reconstr Surg. 2009 Jul;124(1):298-306. doi: 10.1097/PRS.0b013e3181a8072f.

  PMID: 19568092 BACKGROUND

• Greenhalgh DG. Management of Burns. N Engl J Med. 2019 Jun 13;380(24):2349-2359. doi: 10.1056/NEJMra1807442. No abstract available.

  PMID: 31189038 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Jutta Renate Lehmann, Dr.

CONTACT

+39 3391023866; juttarenate.lehmann@auslromagna.it

Davide Griffa, Dr.

CONTACT

+39 3409035237; davide.griffa2@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will act as their own control, receiving the experimental treatment (Blue Light + standard treatment) on one site and the standard treatment on the other

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: September 29, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)